Mastering Every Detail
Achieving Exceptional Quality
Suzhou Shenyun Medical Equipment Co., Ltd. is located in the Wuzhong District of Suzhou, the economic hub of the Yangtze River Delta. Nestled by the beautiful Taihu Lake and adjacent to Shanghai, our company benefits from convenient transportation and a highly advantageous geographical location.
We specialize in the manufacturing and research and development of bariatric surgical instruments, dedicated to improving the lives of patients worldwide through high-quality medical devices and technology. We understand that our products directly impact patient lives, and therefore, we maintain a rigorous and meticulous approach in all aspects of our operations, continuously striving for improvement.
In collaboration with chief physicians from Peking Union Medical College Hospital, we transform patented technologies into products. Our company is responsible for product design, development, manufacturing, and registration. With multiple international certifications, including ISO 13485, CE, FDA 510(k) (fascial closure system), and NMPA, our products are exported to over 50 countries and regions worldwide.
Development Milestones
Over a decade of dedicated craftsmanship, from establishment to globalization
Predecessor Established
The predecessor of Shenyun Medical (DILE) was officially established in Wuzhong District, Suzhou, focusing on the R&D and manufacturing of hard plastic products.
Shenyun Medical Established
The successful development of the cross drainage catheter marked the company's transition from hard plastic products to commercial operation in the medical device market.
New Factory Completed and Official Entry into Bariatric Surgery Field
The modern production base at No. 666 Yinzang Road, Linhu Town, Wuzhong District, Suzhou (total construction area 4000 square meters) was officially put into operation; in the same year, in-depth cooperation with Peking Union Medical College Hospital was initiated, transforming patented technology into products, officially entering the field of bariatric surgical instruments.
ISO 13485 Certification
Obtained ISO 13485:2016 certification for international medical device quality management system, establishing a full-process quality management system compliant with international standards.
NMPA Class II Registration Approved
Obtained NMPA Class II medical device registration certificate for gastric calibration tubes, marking a significant step towards compliance in the field of bariatric surgical instruments.
SFDA Certification and Patent Authorization
Obtained Saudi Arabian SFDA medical device certification, officially entering the Saudi Arabian market; in the same year, multiple core patents were successfully authorized, continuously deepening technological accumulation.
CE, NMPA Certification
Core products successively passed international certifications such as EU CE and China NMPA, with products covering over 50 countries and regions globally.
US FDA 510(k) Clearance
Our fascial closure system received US FDA 510(k) clearance (Class II), the company's first product cleared for the US market.